Efficacy of denosumab in Indian postmenopausal women with osteoporosis

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Efficacy of denosumab in Indian postmenopausal women with osteoporosis
Key Take-Away: 

Apart from calcium and vitamin D supplements being used to treat osteoporosis in post menopausal women, Denosumab, a human monoclonal antibody, is a new class of treatment, which is approved by FDA for the treatment of osteoporosis in postmenopausal women.

Osteoporosis is a serious condition affecting up to 50% of Indian postmenopausal women. Denosumab reduces bone resorption by targeting the receptor activator of nuclear factor‑κB ligand. This study assessed the efficacy and safety of denosumab in Indian postmenopausal women with osteoporosis. 

ABSTRACT: 
Background: 

Osteoporosis is a serious condition affecting up to 50% of Indian postmenopausal women.

Denosumab reduces bone resorption by targeting the receptor activator of nuclear factor‑κB ligand. This study assessed the efficacy and safety of denosumab in Indian postmenopausal women with osteoporosis. 

Methods: 

In this double-blind, multicenter, phase 3 study, 250 Indian postmenopausal women aged 55 to 75 years (T‑score <‑2.5 and >‑4.0 at the lumbar spine or total hip; serum 25(OH) D levels ≥20 ng/mL) were randomized to receive one subcutaneous dose of denosumab 60 mg or placebo. 

All subjects received oral calcium ≥1000 mg and vitamin D3 ≥ 400 IU daily. The primary endpoint was mean percent change in bone mineral density (BMD) at the lumbar spine from baseline to month 6. Secondary endpoints included mean percent change from baseline in BMD at total hip, femoral neck, and trochanter at Month 6 and median percent change from baseline in bone turnover markers at Months 1, 3, and 6.

Results: 

Total 225 subjects (denosumab = 111, placebo = 114) completed the six‑month study. Baseline demographics were similar between groups. 

A 3.1% (95% confidence interval, 1.9%, 4.2%) increase favoring denosumab versus placebo was seen for the primary endpoint (P < 0.0001). Denosumab demonstrated a significant treatment benefit over placebo for the secondary end points. There were no fractures or withdrawals due to adverse events.

 

Conclusion: 

Consistent with results from studies conducted in other parts of the world, denosumab was well tolerated and effective in increasing BMD and decreasing bone turnover markers over a six‑month period in Indian postmenopausal women.

Indian journal of endocrinology and metabolism 2015 Jan; 19(1):148-54

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